CareDx Describes Extensive Analytical Validation Data on AlloSure Robustness at American Association of Clinical Chemistry Annual Meeting

CareDx, Inc. (NASDAQ:CDNA), a molecular diagnostics company focusing on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, described rigorous evidence of the analytical robustness of AlloSure testing at the annual American Association of Clinical Chemistry Annual Meeting on Wednesday, August 2, 2017.

Two presentations highlighted the best-in-class analytical performance of AlloSure, CareDx’s non-invasive laboratory developed test intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of invasive kidney biopsy.

  • B-443: Evaluation of Cell-Free DNA Recovery During Extraction Using a Next Generation Sequencing Assay
  • B-444: Standardized Reagent Formulation and Data-driven QC Criteria Ensure Efficient and Consistent Delivery of Plasma Cell-free DNA Results for Organ Transplant Rejection

The studies presented demonstrate the reproducibility, linearity and robust recovery of cell free DNA (cfDNA) from patient plasma, and the development of clinical-grade standardized reagents and cGMP processes used in the manufacture of AlloSure. “This level of analytical assay development, process control, and integration of National Institute of Standards and Technology first genome reference material provides the utmost confidence in the accurate measurement of the exceptionally low amounts of donor derived cfDNA found in kidney transplant patients,” states Mitch Nelles, Ph.D. Chief Operating Officer of CareDx.

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value solutions for transplant recipients. CareDx offers products across the transplant testing continuum, including AlloMap® and AlloSure™ for post-transplant surveillance and Olerup SSP®, Olerup QTYPE®, and Olerup SBT™ for pre-transplant HLA testing.

For more information, please visit: http://www.CareDx.com.

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